If a study is not configured to allow sites to make data changes themselves, they can submit data change requests. These data change requests can be tracked, reviewed, and approved in Study Home. All Study Home users can track and review the data change requests as long as the user is not restricted from viewing survey data, but only Data Manager and Lead Data Managers are able to approve or reject requests.
The following statuses are used to help you keep track of where the request is at in the submission process:
- Submitted: A site user submitted the request, but it has not yet been reviewed.
- Approved: A Data Manager approved the request.
- Rejected: A Data Manager rejected the request. Site users can submit a new data change request, but they cannot reopen a request that has been rejected.
- Canceled: The site user canceled the request before it was completed.
- Completed: The site user completed the approved data change request.
All requests must be completed by the site, if applicable, before you can lock the site.
Along with tracking the number of request submissions, approvals, completions, and rejections, the following charts are available to help you track change request patterns:
- Data change lag by window
- Data changes by site
- Data changes by survey
- Data changes by survey type
Reviewing and Approving a Data Change Request
- In Study Home, select the Data Changes tab.
- Select Submitted Requests.
- Select View Request in any row. A Data Change Request view opens with information about the request.
- Add your approval or rejection:
- Approve: Select Approve Request.
- Reject: Select a Reason for Rejecting, add a reason if needed, and select Reject Request.
Your response is tracked, and the system sends an email to the site user to let them know your decision. You can view the Rejected Requests, Approved Requests, and Completed Changes cards to view the related requests as their statuses change.
Sending a Data Change Approval Reminder to the Site
If you approved a data change request the change has not been made, you can send a reminder to the site.
- In Study Home, select the Data Changes tab.
- Select Approved Requests. You can review the Days Since Approved column to help identify the approval you want to send a reminder for.
- Select View Request in the row.
- Select Send Reminder to Site.
A notification is sent to the site user who submitted the data change request.